No. 13-16833

IN THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF

AMERICA; GENERIC PHARMACEUTICAL ASSOCIATION;

BIOTECHNOLOGY INDUSTRY ORGANIZATION,

Plaintiffs-Appellants,

v.

ALAMEDA COUNTY, CALIFORNIA; ALAMEDA COUNTY

DEPARTMENT OF ENVIRONMENTAL HEALTH,

Defendants-Appellees.

On Appeal from the United States District Court

for the Northern District of California

Case No. 3:12-CV-06203-RS

Honorable Richard Seeborg, District Judge

BRIEF OF AMICI CURIAE THE CALIFORNIA STATE ASSOCIATION

OF COUNTIES AND THE LEAGUE OF CALIFORNIA CITIES, IN

SUPPORT OF DEFENDANTS-APPELLEES

ORRY P. KORB, County Counsel (Cal. Bar # 114399)

DANNY Y. CHOU, Assistant County Counsel (Cal. Bar # 180240)

GRETA S. HANSEN, Lead Deputy County Counsel (Cal. Bar # 251471)

MARLENE M. DEHLINGER, Litigation Fellow (Cal. Bar # 292282)

OFFICE OF THE COUNTY COUNSEL, COUNTY OF SANTA CLARA

70 West Hedding Street, East Wing, Ninth Floor

San José, California 95110-1770

Telephone: (408) 299-5900

Attorneys for Amici Curiae

California State Association of Counties and League of California Cities

i

RULE 26.1 CORPORATE DISCLOSURE STATEMENT

Pursuant to Rule 26.1 of the Federal Rules of Appellate Procedure, amicus

curiae the California State Association of Counties avers that it is a nonprofit

mutual benefit corporation, which does not offer stock and which is not a

subsidiary or affiliate of any publicly-owned corporation.

Pursuant to Rule 26.1 of the Federal Rules of Appellate Procedure, amicus

curiae the League of California Cities avers that it is a nonprofit mutual benefit

corporation, which does not offer stock and which is not a subsidiary or affiliate of

any publicly-owned corporation.

ii

RULE 29 STATEMENTS

This brief of amici curiae is submitted under Federal Rule of Appellate

Procedure 29(a).

In accordance with Circuit Rule 29-3 (Circuit Advisory Committee Note),

counsel of record received timely notice of the intent of these amici curiae to file

this brief, and all parties have consented to the filing of this brief.

Pursuant to Federal Rule of Appellate Procedure 29(c)(5), the California

State Association of Counties and the League of California Cities state that no

party’s counsel has authored this amicus curiae brief in whole or in part; no party

or party’s counsel has contributed money intended to fund the preparation or

submission of this brief; and no person or entity other than the California State

Association of Counties and the League of California Cities, their members, and

their counsel has contributed money intended to fund the preparation or submission

of this brief.

i

TABLE OF CONTENTS

RULE 26.1 CORPORATE DISCLOSURE STATEMENT ...................................... i

RULE 29 STATEMENTS ........................................................................................ ii

IDENTITY AND INTERESTS OF AMICI CURIAE ............................................... 1

I. INTRODUCTION ........................................................................................... 2

II. ARGUMENT ................................................................................................... 3

A. Under the Dormant Commerce Clause, Local Governments May

Enact Non-Discriminatory Laws that Affect But Do Not Substantially

Burden Interstate Commerce ................................................................. 3

B. As Part of Their Traditional Authority to Regulate Waste Disposal,

Local Governments Have Long Had the Power to Place the

Responsibility of Waste Disposal on Private Entities. .......................... 5

C. “Shifting” Costs of Waste Disposal from Alameda County to Private

Actors Is Well Within the County’s Authority ..................................... 6

D. The Ordinance Is Not An “Extraterritorial” or Direct Regulation of

Interstate Commerce.............................................................................. 8

E. The Fact that Other Jurisdictions May Impose Similar Requirements

on Producers Does Not Render the Ordinance Unconstitutional ........11

F. The Existence of Alternative Means to Achieve the Ordinance’s

Purpose is Irrelevant ............................................................................13

III. CONCLUSION ..............................................................................................15

STATEMENT OF RELATED CASES ...................................................................16

CERTIFICATE OF COMPLIANCE .......................................................................17

ii

TABLE OF AUTHORITIES

Page

CASES

Ass’n des Eleveurs de Canards et d’Oies du Quebec v. Harris

729 F.3d 937 (9th Cir. 2013) .................................................................................10

Chemical Specialties Mfrs. Ass’n, Inc. v. Allenby

958 F.2d 941 (9th Cir. 1992) .................................................................................10

Committee of Dental Amalgam Mfrs. & Distributors v. Stratton

92 F.3d 807 (9th Cir. 1996) ...................................................................................10

CTS Corp. v. Dynamics Corp. of Am.

481 U.S. 69 (1987) .................................................................................................. 4

Dep’t of Revenue v. Davis

553 U.S. 328 (2008) ................................................................................................ 4

Exxon Corp. v. Governor of Md.

437 U.S. 117 (1978) ..........................................................................................8, 12

Great Atl. & Pac. Tea Co., Inc. v. Cottrell

424 U.S. 366 (1976) ................................................................................................ 4

Kleenwell Biohazard Waste & Gen. Ecology Consultants, Inc. v. Nelson

48 F.3d 391 (9th Cir. 1995) ...............................................................................5, 13

Maine v. Taylor

477 U.S. 131 (1986) ................................................................................................ 4

Nat’l Ass’n of Optometrists & Opticians v. Harris

682 F.3d 1144 (9th Cir. 2012) ....................................................................... passim

Nat'l Elec. Mfrs. Ass’n v. Sorrell

272 F.3d 104 (2d Cir. 2001) ....................................................................... 8, 10, 12

Pharm. Research & Mfrs. Ass’n of Am. v. Walsh

538 U.S. 644 (2003) ................................................................................................ 8

Pike v. Bruce Church, Inc.

397 U.S. 137 (1970) ..........................................................................................5, 13

Rocky Mountain Farmers Union v. Corey

730 F.3d 1070 (9th Cir. 2013) ........................................................................ 10, 12

iii

S.D. Myers, Inc. v. City & County of San Francisco

253 F.3d 461 (9th Cir. 2001) .................................................................................11

South–Central Timber Dev., Inc. v. Wunnicke

467 U.S. 82 (1984) .................................................................................................. 3

Toy Mfrs. of America, Inc. v. Blumenthal

986 F.2d 615 (2d Cir. 1993) ..................................................................................10

United Haulers Ass’n, Inc. v. Oneida-Herkimer Solid Waste Mgmt. Auth.

550 U.S. 330 (2007) ...................................................................................... passim

USA Recycling, Inc. v. Babylon

66 F.3d 1272 (2d Cir. 1995) ................................................................................5, 6

STATUTES

Alameda County General Ordinance Code § 6.53.040(B)(3) ................................... 7

1

IDENTITY AND INTERESTS OF AMICI CURIAE

The California State Association of Counties and the League of California

Cities (hereinafter collectively referred to as “amici”) respectfully submit this

amicus curiae brief in support of Defendants-Appellees County of Alameda and

Alameda County Department of Environmental Health (hereinafter “Alameda

County” or “Alameda”).

The California State Association of Counties (“CSAC”) is a non-profit

corporation with a membership consisting of 58 California counties. CSAC

sponsors a Litigation Coordination Program, which is administered by the County

Counsels’ Association of California and overseen by the Association’s Litigation

Overview Committee, comprised of county counsels throughout the state. The

Litigation Overview Committee monitors litigation of concern to counties

statewide and determined that this is such a case.

The League of California Cities is an association of 470 California cities

dedicated to protecting and restoring local control to provide for the public health,

safety, and welfare of their residents, and to enhance the quality of life for all

Californians. The League is advised by its Legal Advocacy Committee, comprised

of 24 city attorneys from all regions of the State. The Committee monitors

litigation of concern to municipalities, and identifies those cases that have

2

statewide or nationwide significance. The Committee has identified this case as

having such significance.

I.

INTRODUCTION

In 2012, Alameda County enacted the Safe Drug Disposal Ordinance (“the

Ordinance”) to protect its residents from the many environmental and health-

related harms associated with unsafe disposal of unused prescription medications.

The Ordinance requires that producers of prescription drugs (“Producers”) sold in

Alameda County create and fund programs that facilitate the safe disposal of

unused drugs, thereby decreasing their risk to public health and the environment.

In so doing, Alameda elected to place the responsibility and costs associated with

safe drug disposal on the corporations that manufacture and make hundreds of

millions of dollars in profits from drugs sold within the county, rather than placing

that burden on the public at large.

Three organizations representing the interests of pharmaceutical

manufacturers (collectively “PhRMA”) brought a facial challenge to the

Ordinance, alleging it violates the dormant Commerce Clause. It is no accident

that PhRMA’s brief is long on hyperbole and short on discussion of relevant case

law. Indeed, PhRMA ignores controlling authority and asks this Court to adopt a

rule that would invalidate a wide array of state and local laws, thereby curtailing

3

the longstanding authority of state and local governments to regulate waste

disposal. Amici urge this Court to decline Appellants’ invitation to depart from

long-established Commerce Clause jurisprudence, and affirm the District Court’s

judgment.

II.

ARGUMENT

A. Under the Dormant Commerce Clause, Local Governments May Enact

Non-Discriminatory Laws that Affect But Do Not Substantially Burden

Interstate Commerce

The Commerce Clause, which vests Congress with the authority to regulate

interstate commerce, implicitly imposes “limitation[s] on the power of the States

[and local governments] to enact laws imposing substantial burdens on [interstate]

commerce.” Nat’l Ass’n of Optometrists & Opticians v. Harris, 682 F.3d 1144,

1147 (9th Cir. 2012) (“Optometrists”) (citing South-Central Timber Dev., Inc. v.

Wunnicke, 467 U.S. 82, 87 (1984)).

“Modern dormant Commerce Clause jurisprudence primarily is driven by

concern about economic protectionism . . . The principal objects of dormant

Commerce Clause scrutiny are statutes that discriminate against interstate

commerce. . . Most regulations that run afoul of the dormant Commerce Clause do

so because of discrimination.” Id. at 1148 (quoting Dep’t of Revenue v. Davis, 553

4

U.S. 328, 337-38 (2008) and CTS Corp. v. Dynamics Corp. of Am., 481 U.S. 69, 87

(1987)).

But “in a small number of dormant Commerce Clause cases courts also have

invalidated statutes that imposed other significant burdens on interstate commerce”

even though they are non-discriminatory. Id. In these cases, “[a] critical

requirement for proving a violation of the dormant Commerce Clause is that there

must be a substantial burden on interstate commerce.” Id. (emphasis in original).

Indeed, “[t]he limitation imposed by the Commerce Clause on state

regulatory power is by no means absolute, and the States retain authority

under their general police powers to regulate matters of legitimate local

concern, even though interstate commerce may be affected.” Maine v.

Taylor, 477 U.S. 131, 138 (1986) (internal quotation marks omitted). “[T]he

Supreme Court has recognized that ‘under our constitutional scheme the

States [and local governments] retain broad power to legislate protection for

their citizens in matters of local concern such as public health’ and has held

that ‘not every exercise of local power is invalid merely because it affects in

some way the flow of commerce between the States.’” Optometrists, 682

F.3d at 1148 (quoting Great Atl. & Pac. Tea Co., Inc. v. Cottrell, 424 U.S.

366, 371 (1976)). Thus, a law that is non-discriminatory and only

incidentally burdens interstate commerce will be upheld “unless the burden

5

imposed upon [interstate] commerce is clearly excessive in relation to the

putative local benefits.” Kleenwell Biohazard Waste & Gen. Ecology

Consultants, Inc. v. Nelson, 48 F.3d 391, 399 (9th Cir. 1995) (quoting Pike

v. Bruce Church, Inc., 397 U.S. 137, 142 (1970)).

B. As Part of Their Traditional Authority to Regulate Waste Disposal,

Local Governments Have Long Had the Power to Place the

Responsibility of Waste Disposal on Private Entities

“Waste disposal is both typically and traditionally a local government

function.” United Haulers Ass’n, Inc. v. Oneida-Herkimer Solid Waste Mgmt.

Auth., 550 U.S. 330, 344 (2007). For more than a century “it has been settled law

that garbage collection and disposal is a core function of local government in the

United States.” USA Recycling, Inc. v. Babylon, 66 F.3d 1272, 1275 (2d Cir.

1995). Furthermore, a municipality “has legitimate—indeed, compelling—

interests that are served by its waste management program. In our multi-tiered

federal system, local governments have historically borne primary responsibility

for ensuring the safe and reliable disposal of waste generated within their

borders—a role that Congress has expressly recognized.” Id. at 1288.

State and local “power to regulate commerce is at its zenith in areas

traditionally of local concern,” such as waste disposal. Kleenwell, 48 F.3d at 398.

Furthermore, regulations that protect public safety, including those governing safe

waste disposal, enjoy a “strong presumption of validity.” Id. at 400 n.11.

6

Despite this, PhRMA argues that the Ordinance violates the Commerce

Clause because Alameda County is not exercising its authority over waste disposal,

but is instead “transferring its traditional police power responsibility of waste

disposal to [private] interstate actors[.]” PhRMA Br. at 24. In advancing this

argument, PhRMA evinces a fundamental misunderstanding of the core power of

local governments to regulate waste disposal. Indeed, local governments have

traditionally regulated waste disposal by, among other things, relying “on a closely

regulated private market to provide those services.” USA Recycling, 66 F.3d at

1275; see also United Haulers, 550 U.S. at 344 (“It is not the office of the

Commerce Clause to control the decision of the voters on whether government or

the private sector should provide waste management services.”). Thus, PhRMA’s

suggestion that there is something unusual—much less unconstitutional—about a

regulatory scheme under which private entities undertake waste disposal is

baseless.

C. “Shifting” Costs of Waste Disposal from Alameda County to Private

Actors Is Well Within the County’s Authority

PhRMA argues that Alameda County’s decision to “shift” the costs of drug

disposal to Producers violates the dormant Commerce Clause by favoring local

interests and by directly burdening interstate commerce. PhRMA Br. at 29-31, 39-

43. PhRMA asserts that “local laws that transfer regulatory costs away from local

interests to whom the enacting governments are accountable and toward

7

unrepresented external entities give rise to the recognized danger that . . . the

burden falls on economic interests” with little or no influence in the local political

process, thereby violating the Commerce Clause. PhRMA Br. at 30 (emphasis in

original). But as Alameda County notes, nothing in the Ordinance precludes

Producers from passing along the costs of compliance to the Alameda County

electorate.1 Alameda Br. at 48-51. If the electorate believes the costs of the

Ordinance outweigh its benefits, the electorate will demand its repeal. As such, the

“danger” that Producers must bear costs imposed by political actors they have no

ability to influence is illusory.

PhRMA’s assertion that, as a practical matter, Producers will not pass along

these costs is of no moment. Even if Producers will likely choose not to pass along

these costs because of the complexity of the supply chain or because the costs to be

recouped would amount to a fraction of a penny per prescription, this has no

1 PhRMA argues that the Ordinance “expressly exempts local consumers from

any point-of-sale fee related to collection and disposal costs” and thereby ensures

that these costs “will be exclusively paid for by consumers outside of Alameda.”

PhRMA Br. at 43. Section 6.53.040(B)(3) of the Ordinance, upon which PhRMA

bases this argument, states that “No Person or Producer may charge a specific

point-of-sale fee to consumers to recoup the costs of their Product Stewardship

Program, nor may they charge a specific point-of-collection fee at the time the

Unwanted Products are collected from Residential Generators or delivered for

disposal.” ER 124 (emphasis added). As Alameda argues, the Ordinance only

precludes the addition of a specific point-of-sale fee on drug purchases; it does not

preclude a price increase on drugs sold in Alameda County for purposes of

recouping compliance costs. Alameda Br. at 48-51. Indeed, PhRMA conceded

this point before the District Court. See Plaintiffs’ Reply in Supp. of Summ. J. at

22-24, Docket Entry 33 at 27-29.

8

bearing on the Commerce Clause inquiry. Nat’l Elec. Mfrs. Ass’n v. Sorrell, 272

F.3d 104, 110-11 (2d Cir. 2001) (holding that a manufacturer’s unwillingness or

practical inability to modify its production and distribution processes to recoup

costs does not give rise to a Commerce Clause violation).

Furthermore, even if the Ordinance prohibited Producers from passing along

the costs, it would still pass constitutional muster. The Supreme Court has held

that imposing financial burdens on private actors in order to protect the public fisc

is a legitimate objective for purposes of the Commerce Clause. United Haulers,

550 U.S. at 346; see also Pharm. Research & Mfrs. Ass’n of Am. v. Walsh, 538

U.S. 644, 669-70 (2003). Furthermore, federal courts have consistently rejected

the notion that the Commerce Clause protects businesses against regulations that

may reduce their profit margin. Exxon Corp. v. Governor of Md., 437 U.S. 117,

127 (1978); Optometrists, 682 F.3d at 1152 n.11, 1154-55; Sorrel, 272 F.3d at 111.

Thus, even if Producers were precluded from passing their compliance costs on to

Alameda County residents, the Ordinance would not violate the Commerce Clause.

D. The Ordinance Is Not An “Extraterritorial” or Direct Regulation of

Interstate Commerce

PhRMA and amicus curiae the U.S. Chamber of Commerce argue that

Alameda County’s Ordinance impermissibly regulates commerce extraterritorially

because it imposes burdens on pharmaceutical companies with “no connection” to

the county. PhRMA Br. at 25-26; Chamber Br. at 5. Specifically, PhRMA

9

suggests that because the Ordinance imposes duties and costs on Producers whose

products arrive in Alameda County “through a complex chain of wholesalers and

intermediaries” operating outside the county, any regulation of those Producers

impermissibly regulates and burdens interstate commerce. PhRMA Br. at 3-4, 13,

28-29; ER 85 (¶ 20).

Alameda County and amicus curiae Natural Resources Defense Council

(NRDC) identify the controlling authority definitively rejecting such arguments

and we will not repeat those legal arguments. We note, however, that PhRMA and

the Chamber’s position defies credulity. Producers spend millions of dollars

marketing their products in Alameda County each year, and reaped a staggering

$965 million in revenue based on sales of pharmaceuticals in Alameda County in

2010 alone. ER 87 (¶ 34). This is more than a sufficient “connection” to justify

the Ordinance.

Moreover, taken to its logical conclusion, the rule advocated by PhRMA and

the Chamber would allow a manufacturer to exempt itself from any state or local

regulation by using an intermediary outside the jurisdiction to put its product into

the stream of commerce.

In any event, state and local laws imposing costs on manufacturers to protect

local residents from harms associated with products that arrive through a national

10

chain of commerce involving multiple intermediaries are commonplace.2 As this

Court recently held, “[t]he Commerce Clause does not protect Plaintiffs’ ability to

make others pay for the hidden harms of their products merely because those

products are shipped across state lines.” Rocky Mountain Farmers Union, 730

F.3d at 1106. To hold that state or local governments are precluded from

regulating products sold through out-of-state middlemen would substantially

curtail their ability to protect public health and safety and would improperly limit

the scope of their core regulatory powers.

/ / /

/ / /

2 See, e.g., Rocky Mountain Farmers Union v. Corey, 730 F.3d 1070, 1078

(9th Cir. 2013) (noting that “[s]ince 1957, California has acted at the state level to

regulate air pollution from motor vehicles” while rejecting a Commerce Clause

challenge to recent state regulations regarding fuel production and greenhouse gas

emissions); Ass’n des Eleveurs de Canards et d’Oies du Quebec v. Harris, 729

F.3d 937 (9th Cir. 2013) (rejecting a dormant Commerce Clause Challenge to a

California law requiring foie gras producers to adopt certain production processes

in order for their products to be sold in California); Committee of Dental Amalgam

Mfrs. & Distributors v. Stratton, 92 F.3d 807 (9th Cir. 1996) (rejecting a

preemption challenge to a California law requiring manufactures to include

additional labels on hazardous products); Chemical Specialties Mfrs. Ass’n, Inc. v.

Allenby, 958 F.2d 941 (9th Cir. 1992) (same); Sorrell, 272 F.3d 104 (2d Cir. 2001)

(rejecting a dormant Commerce Clause challenge to a Vermont law requiring

manufacturers of mercury-containing products to include specific labels on any

such products sold within Vermont); Toy Mfrs. of America, Inc. v. Blumenthal, 986

F.2d 615 (2d Cir. 1993) (rejecting a preemption challenge to a Connecticut law

requiring toy manufactures to include additional labels on products sold in

Connecticut).

11

E. The Fact that Other Jurisdictions May Impose Similar Requirements

on Producers Does Not Render the Ordinance Unconstitutional

PhRMA and its amici argue that the Ordinance violates the dormant

commerce clause because “[w]idespread adoption of Ordinance-like laws would

‘stifle’ the interstate market by making interstate businesses liable for the full costs

of running waste-disposal programs in every county where their products are sold.”

PhRMA Br. at 44. This argument likewise is meritless.

First, for the Ordinance to be invalidated on this basis, PhRMA must “either

present evidence that conflicting, legitimate legislation is already in place or that

the threat of such legislation is both actual and imminent.” S.D. Myers, Inc. v. City

& County of San Francisco, 253 F.3d 461, 469-70 (9th Cir. 2001). It does neither.

Instead, PhRMA points only to a nearly identical ordinance enacted by King

County, Washington, and a similar law pending before the California legislature.

PhRMA Br. at 45. Those pieces of legislation do not “conflict” with the

Ordinance, and do not suggest that the threat of conflicting laws is actual, much

less imminent.

Second, any interference with interstate commerce resulting from

widespread enactment of laws like the Ordinance would be minimal. As the facts

to which PhRMA stipulated make clear, the costs to Producers of compliance with

the Ordinance are trivial relative to the revenues generated through pharmaceutical

sales in Alameda County, and the same would likely be true of similar laws in

12

other jurisdictions. See ER 86-87 (¶¶ 28, 30, 34). Thus, there is no basis for

suggesting that Producers’ ability to market and distribute their products would be

“stifled” by the widespread enactment of similar legislation. And even if

widespread adoption of laws like the Ordinance do reduce Producers’ profits, such

a consequence would not give rise to a Commerce Clause violation. Exxon Corp.,

437 U.S. at 127; Optometrists, 682 F.3d at 1152 n.11, 1154-55; Sorrel, 272 F.3d at

111.

Finally, and most importantly, if this Court were to accept PhRMA’s

position that the Ordinance should be invalidated based on the prospect that other

jurisdictions may adopt similar laws, legislative innovation would be stifled:

If [courts] were to invalidate [a] regulation every time another state

considered a complementary statute, we would destroy the states’ ability to

experiment with regulation. Successful experiments inspire imitation both

vertically, as when the federal government followed California’s lead on air

pollution, and horizontally, as shown by the federal Organic Foods

Production Act of 1990, 7 U.S.C. §§ 6501–23, adopted after twenty-two

states, starting with Oregon, enacted organic food labeling standards. See

Or.Rev.Stat. § 632.925 (1973); S.Rep. No. 357, reprinted in 1990

U.S.C.C.A.N. 4656, 4943. After nearly half of the states acted, Congress

provided a uniform standard. As it did there, Congress may decide that

uniformity [in drug disposal legislation] is warranted . . . If it does so after

several states [or municipalities] have acted, it will have the benefit of their

experiments. But when or if such uniformity is desirable is not a question

for courts. The proliferation of organic labeling standards did not threaten

our economic union, and the possibility that many [jurisdictions] might

[require drug manufactures to dispose of products] sold within their borders

does not risk the “competing and interlocking local economic regulation that

the Commerce Clause was meant to preclude.”

Rocky Mountain Farmers Union, 730 F.3d at 1105.

13

F. The Existence of Alternative Means to Achieve the Ordinance’s Purpose

is Irrelevant

Where, as here, a non-discriminatory law is “directed to legitimate local

concerns” and its “effects upon interstate commerce are only incidental,” courts

apply the balancing test set forth in Pike, and will reject a challenge under the

Commerce Clause “unless the burden imposed on interstate commerce is clearly

excessive in relation to the putative local benefits.” United Haulers, 550 U.S. at

346 (internal quotation marks and citations omitted). “As the party challenging the

regulation, [PhRMA] must establish that the burdens that the regulation imposes

on interstate commerce clearly outweigh the local benefits arising from it.”

Kleenwell, 48 F.3d at 399.

PhRMA argues that the Ordinance cannot satisfy even the deferential Pike

standard because it “yields no public benefits while imposing burdens on interstate

commerce” as “pharmaceutical-collection efforts would achieve precisely the same

effects if performed by the County and financed by a local waste-disposal fee,

rather than conducted and paid for by Appellants.” PhRMA Br. at 59. This

argument is also baseless.

First, contrary to its assertion that the Ordinance “yields no public benefits,”

PhRMA stipulated that the “environmental, health and safety benefits [of the

Ordinance] are not contested[.]” ER 87; see also Alameda Br. at 8-10 (identifying

14

numerous scientific studies establishing the substantial harms associated with

improper drug disposal).

Second, PhRMA offers no support whatsoever for its assertion that the

Ordinance is merely a cost shifting measure that does not significantly expand

upon current drug disposal programs operated by Alameda County. Because it

bears the burden of proof, PhRMA’s failure to cite any evidence in support of its

arguments is fatal.

Third, as noted above, the Supreme Court held in United Haulers that

revenue generation or cost avoidance by a governmental entity is a legitimate

interest. United Haulers, 550 U.S. at 346.

Finally, PhRMA’s argument that the Ordinance must be struck down

because a drug disposal program paid for by Alameda would be equally effective

and impose a lesser burden on interstate commerce was rejected in Optometrists.

Optometrists, 682 F.3d at 1157. There, this Court held that an examination of

alternatives is only required under the Commerce Clause where a law is

discriminatory, thereby triggering a heightened standard of review. Id. By

declining to challenge the District Court’s finding that the Ordinance is non-

discriminatory, PhRMA essentially concedes this point. Furthermore, the

Ordinance does not impose a significant burden on interstate commerce. As such,

15

this Court need “not consider any evidence regarding alternative means for the

[county] to achieve its goals.” Optometrists, 682 F.3d at 1157.

III.

CONCLUSION

For the reasons set forth above, and those in the briefs of Defendant

Alameda County and amicus Natural Resources Defense Council, the District

Court’s order denying Plaintiff’s motion for summary judgment and granting

Alameda County’s cross-motion should be affirmed.

Dated: January 22, 2014

Respectfully submitted,

ORRY KORB

COUNTY COUNSEL

By: /S/ .

GRETA HANSEN

Lead Deputy County Counsel

/S/ . MARLENE DEHLINGER Litigation Fellow

Attorneys for amici curiae the

California State Association of

Counties and the League of

California Cities

16

STATEMENT OF RELATED CASES

Attorneys for amici are not aware of any related cases pending in this Court,

as defined in Ninth Circuit Rule 28-2.6.

Dated: January 22, 2014

Respectfully submitted,

ORRY KORB

COUNTY COUNSEL

By: /S/ .

GRETA HANSEN

Lead Deputy County Counsel

/S/ . MARLENE DEHLINGER Litigation Fellow

Attorneys for amici curiae the

California State Association of

Counties and the League of

California Cities

17

CERTIFICATE OF COMPLIANCE

I certify that, pursuant to Federal Rule of Appellate Procedure 32(a)(7)(c)

and Ninth Circuit Rule 32-1, the attached amicus curiae brief is proportionately

spaced, has a typeface of 14 points or more, and contains approximately 3,389

words.

Dated: January 22, 2014

Respectfully submitted,

ORRY KORB

COUNTY COUNSEL

By: /S/ .

GRETA HANSEN

Lead Deputy County Counsel

/S/ . MARLENE DEHLINGER Litigation Fellow

Attorneys for amici curiae the

California State Association of

Counties and the League of

California Cities

1

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

CERTIFICATE OF ELECTRONIC SERVICE

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA;

GENERIC PHARMACEUTICAL ASSOCIATION; BIOTECHNOLOGY

INDUSTRY ORGANIZATION, v. ALAMEDA COUNTY, CALIFORNIA;

ALAMEDA COUNTY DEPARTMENT OF ENVIRONMENTAL HEALTH

Case No. 13-16833

I hereby certify that I electronically filed the foregoing

BRIEF OF AMICI CURIAE THE CALIFORNIA STATE ASSOCIATION

OF COUNTIES AND THE LEAGUE OF CALIFORNIA CITIES, IN

SUPPORT OF DEFENDANTS-APPELLEES

with the Clerk of the Court for the United States Court of Appeals for the Ninth

Circuit by using the appellate CM/ECF system on January 22, 2014.

I certify that all participants in the case are registered CM/ECF users and

that service will be accomplished by the appellate CM/ECF system.

/S/ .

Alexandra K. Weight